Class IIReported 2025-04-09

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13

Recalled by BIOCON PHARMA INC

Reason for Recall

Failed dissolution specifications: lower than specifications

Recall Number

D-0306-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-17

Reported

2025-04-09

Distribution

U.S.A. nationwide

Code Info

Lot#: AVC24035, Exp 03/31/26

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.